Amlodipine Pregnancy Warnings
This drug should be used during pregnancy only if the benefit outweighs the risk to the fetus (AU, US)
Use is contraindicated (UK)
AU TGA pregnancy category: C
US FDA pregnancy category: C
Comments:
-Use of adequate methods of contraception should be encouraged.
-If this drug is used during pregnancy, or if the patient becomes pregnant while taking this drug, the patient should be apprised of the potential harm to the fetus.
Animal studies have shown significantly decreased litter size, increased intrauterine deaths and prolongation of gestation and duration of labor when this drug was given before mating, throughout mating, and during gestation. There are no controlled data in human pregnancy.
Reversible biochemical changes in the head of spermatozoa occurred in some patients treated with calcium channel blockers. There are no controlled data for this drug, but animal models have shown adverse effects on male fertility.
AU TGA pregnancy category C: Drugs which, owing to their pharmacological effects, have caused or may be suspected of causing, harmful effects on the human fetus or neonate without causing malformations. These effects may be reversible. Accompanying texts should be consulted for further details.
US FDA pregnancy category C: Animal reproduction studies have shown an adverse effect on the fetus and there are no adequate and well-controlled studies in humans, but potential benefits may warrant use of the drug in pregnant women despite potential risks.
See references
Amlodipine Breastfeeding Warnings
Use is not recommended and a decision should be made to discontinue breastfeeding or discontinue the drug, taking into account the importance of the drug to the mother (AU, US)
Use is contraindicated (UK)
Excreted into human milk: Yes
Comments:
-The effects in the nursing infant are unknown.
-Infants exposed to this drug should be closely monitored.
See references